The Sherrilyn and Ken Fisher Center for Environmental Infectious Diseases Discovery Program Johns Hopkins University, School of Medicine, Department of Medicine, Division of Infectious Diseases The Fisher Center Discovery Program Application Guidelines Application Deadline Eligible Budget Number Available Grant Period Application Award Notification Award Start November 15, 2012 All Johns Hopkins faculty (Fellow, house staff or student proposals must be supported by a faculty member mentor) Up to $50,000 Maximum 5 projects will be funded Twelve months, with a 12 month extension upon competitive review Online at http://ictr.johnshopkins.edu/ictr/ Follow the links to Connection Request and Fisher Center Discovery Program On or before January 15, 2013 February 1-July 1, 2013, at investigator discretion Program Objectives The Fisher Center Discovery Program (FCDP) is designed to accomplish the following objectives To promote research by providing funds that will support projects focused on clinical or translational research related to environmental infectious diseases (ID). Environmental ID includes disease causing agents found in traditional ecological environments, such as air, soil, and water, in addition to vector-borne or zoonotic diseases, as well as those found within human flora and built environments (home, hospital, and community). To provide expertise, resources, services, and mentorship opportunities for pilot or clinical studies that may lack traditional funding mechanisms. To promote novel, cross-disciplinary collaborative clinical research among schools of the Johns Hopkins University. To provide funding for hands-on training and mentoring of young investigators in the science of clinical investigation. Eligibility All faculty members of Johns Hopkins University, especially junior faculty, are encouraged to apply. Only Johns Hopkins University faculty members holding a terminal degree (MD, DO, PhD, PharmD, DVM, or equivalent) may apply as Principal Investigator (PI). Hopkins-affiliated postdoctoral fellows, house staff, medical school students, graduate students, and undergraduate students may submit a FCDP application and be included as research team members on FCDP proposals. However, they may not be the PI. If the applicant is not a faculty member, the supporting Faculty member PI is required to write a letter indicating review and approval of the project. Johns Hopkins University School of Medical (JHU SOM) matriculated candidates for the M.D. degree are encouraged to be included as research team members to supplement funding received through JHU SOM programs. o Such JHU SOM programs include, but are not limited to, AMA Foundation Seed Grant Research Program, Dean’s Year Funding, Dean’s Office Summer Research Funding, Alpha Omega alpha Research Grant, and Research Travel Funds. o JHU SOM research programs are separate from the FCDP. As such, it will be the responsibility of the student to comply with all JHU SOM requirements regarding the application, completion and administration of JHU SOM programs. o All research projects must be carried out at Johns Hopkins with a Johns Hopkins faculty preceptor. o The FCDP application must be accompanied by a letter of support from the Faculty member who is the proposed research preceptor. o Work accomplished on behalf of the FCDP may not be credited toward the achievement of an academic degree without the written permission of the JHU SOM. 1 The Sherrilyn and Ken Fisher Center for Environmental Infectious Diseases Discovery Program Johns Hopkins University, School of Medicine, Department of Medicine, Division of Infectious Diseases o The student’s performance to date in the JHU SOM will be considered in the award process. Therefore, an official transcript from the JHU SOM may be requested. All FCDP projects that involve human participants must be approved by a Johns Hopkins Medicine Institutional Review Board (IRB). Such projects will be carried out using the guidelines and policies developed by the Johns Hopkins Office of Human Subjects Research Compliance Team. All projects that involve animals must be approved by the Johns Hopkins University Institutional Animal Care and Use Committee (IACUC). Such projects will be carried out using the guidelines and policies developed by the IACUC. While advance approval by the IRB and/or IACUC is not a prerequisite for submission of a FCDP application, investigators should be aware of the impact of these and other necessary administrative or regulatory reviews on project timeline and feasibility. If the project does not meet with IRB and/or IACUC approval, FCDP funding will be terminated. If this is a clinical trial, after the FCDP award has been made and the project has received IRB approval, the research project must be registered at clinicaltrials.gov in a timely fashion. Previously awarded FCDP PIs may be eligible to apply for a new FCDP award for a different research project at the conclusion of the original twelve month award period. Re-submission of denied grants is discouraged except by invitation from the FCAB. However, unsuccessful applicants may apply in consecutive rounds with substantially different proposals. Conflicts of Interest At the time of application, before funds are awarded, and throughout the project period, it is the responsibility of the PIs and all members of the research team to report any financial or fiduciary interest that might appear to present a conflict of interest to the FCAB and the University Office of Policy Coordination, using the JHU disclose system. The presence of conflict of interest does not disqualify investigators from receiving this award, but will require the review and management of this conflict by the Committee on Outside interests. The failure of any research team member to disclose all outside interests could result in the termination of the FCDP award and the disallowance of all study costs. Additional information may be found online at www.hopkinsmedicine.org/research/OPC. Project Topics Emphasis will be on understudied and/or traditionally under-funded infectious diseases caused by environmental pathogens causing human illness. Because funding may be found from multiple sources and/or not fit within the theme of environmental infectious diseases; HIV, Hepatitis A/B/C, influenza, and tuberculosis, as examples, will not generally be considered for FCDP awards. FCDP resources will be concentrated on clinical research to generate pilot or more comprehensive data. Laboratory research will only be considered as part of a translational or clinical research project. Collaborative research within the Hopkins community is strongly encouraged. Novel collaboration with nontraditional partners in the Krieger School of Arts and Sciences, Whiting School of Engineering, Carey Business School, School of Education, School of Nursing, Bloomberg School of Public Health, and School of Medicine is strongly encouraged. Projects may cover a wide range of topics relevant to environmental infectious diseases, including but not limited to these representative topics: Clinical Research o Improving the clinical diagnosis and treatment of environmental infectious diseases o Development or evaluation of diagnostic tests or procedures o Characterization of long-term outcomes of environmental infectious diseases o Comparative effectiveness research o Modes of environmental infectious disease transmission 2 The Sherrilyn and Ken Fisher Center for Environmental Infectious Diseases Discovery Program Johns Hopkins University, School of Medicine, Department of Medicine, Division of Infectious Diseases o Prevention of environmental infectious disease o Use and impact of healthcare informatics in environmental infectious disease research o Impact of ecological changes on health and disease Education o Effectiveness of training program development for clinicians concerning the diagnosis and treatment of environmental infectious diseases o Evaluate community education materials, including print, web-based, and social media Animal Research o Animal modeling of environmental infectious diseases o Animal to human transmission of environmental infectious diseases Business and Healthcare Management o Economic impact of environmental infectious diseases o Impact of health care reform on the diagnosis and treatment of environmental infectious diseases Monetary Support Requests must be no more than $50,000. Requests exceeding $50,000 will not be reviewed. Requests that are lower than the $50,000 ceiling are strongly encouraged, and may have a competitive advantage. A realistic budget proportionate to the scope of the project must be included in the FCDP application package. The budget must be submitted using the FCDP Budget Template Grants and non-financial support may be used only for support of research conducted primarily at Johns Hopkins institutions. Subcontracts with outside institutions or facilities are permitted, but should be no more than 50% of the total requested budget. In an effort to support young investigators, there will be no salary support for faculty beyond the level of Assistant Professor. Funds may be used for staff salary or student stipends. Total salary support will be limited to a 50% monetary award cap, unless there is strong justification for an additional level of salary support. Justification for exceeding the 50% cap is to be submitted in the form of a written letter and appended to the application package. Funds may be used for travel essential to the conduct of the research, but not for travel to established meetings or conferences. Funds may be used for equipment specific to the development of an assay, diagnostic, or device. Equipment costs should not be more than 50% of the total grant award. Funds will be released to the PI in the form of an internal order number. Funding will be for a twelve month period, with the award start date between February 1 and July 1, 2013 at the discretion of the PI. After completion of the initial twelve months of the grant award, previously awarded FCDP PIs may apply for an additional support for up to 12 months. This period of extended support is to allow for completion of research projects. All grant extension requests must be submitted before the next FCDP application deadline using the FCDP Award Extension Request form. All requests for award extensions will be reviewed by the Fisher Center Advisory Board (FCAB) who will make the final determination regarding release of additional funds. At the end of the grant period or at the time of early termination, all unspent FCDP funds will be returned to the FCDP. Non-Monetary Support In an effort to prevent duplication of services, investigators are encouraged to apply for monetary and service support from the Johns Hopkins Institute for Clinical and Translational Research (ICTR). FCDP awards may be used to supplement ICTR awards. The FCDP recognizes the importance of non-monetary support in the form of mentorship and research support. 3 The Sherrilyn and Ken Fisher Center for Environmental Infectious Diseases Discovery Program Johns Hopkins University, School of Medicine, Department of Medicine, Division of Infectious Diseases Non-monetary support is pro-rated and will be included in total award calculations (see FCDP Budget Template). Fisher Center provided services must be represented on the FCDP Budget template. Applicants may request non-monetary support on the FCDP Application. Examples of support include: o Study design assistance o Study protocol, consent, and/or forms development assistance o Research database development and maintenance o Institutional Review Board (IRB) assistance o Johns Hopkins Institute for Clinical and Translational Research (ICTR) assistance o Assistance with posting at clinicaltrials.gov o Research record local storage space o Budget management o Petty cash management o Clinical Research Management System (CRMS) management o Coordination with the Investigational Drug Service (IDS) o Other services to be specified by the applicant Post Award Requirements Quarterly, all PIs or their designees will be required to submit a brief written progress report using the FCDP Interim Report form. PIs or their designees will asked to present preliminary research findings at a FCDP designated meeting on a quarterly basis. Failure to submit reports or participate in the meetings will result in termination of funding and non-monetary support. Quarterly, all PIs or their financial management designees will be required to submit a SAP Business Warehouse (BW) Non-sponsored Financial Summary, year to date (YTD). The Summary is to include all negative and positive entries, G/L breakdown, and all rows. The report is to be extrapolated into MS Excel, printed, and submitted along with the quarterly Interim Report. Failure to submit the Financial Summary will result in termination of funding and non-monetary support. At the completion of the research, the PI or designee will orally present the research in a FCDP-mentor approved forum. Publication of research is strongly encouraged. All publications resulting from research using FCDP resources are required to cite the FCDP and ICTR as contributing sources of support. When publishing articles related to this research, the following language should be used in its entirety: This publication was made possible by support from the Sherrilyn and Ken Fisher Center for Environmental Infectious Diseases, Division of Infectious Diseases of the Johns Hopkins University School of Medicine. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of the Fisher Center or Johns Hopkins University School of Medicine. This publication was made possible by Grant Number UL1 RR 025005 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH." Any substantive changes to the original research plan or budget must be discussed with and submitted in writing to the FCDP. Failure to do so will result in termination of funding. Changes must be submitted to the responsible regulatory body (IRB and/or IACUC). The FCDP may suggest revisions to the application, protocol, research plan, budget, IRB application, or other study documents pre or post award. Dissemination Plan FCDP proposals will be accepted one time per year, with a submission deadline of November 15, 2012. 4 The Sherrilyn and Ken Fisher Center for Environmental Infectious Diseases Discovery Program Johns Hopkins University, School of Medicine, Department of Medicine, Division of Infectious Diseases University-wide web and email announcements will be sent at least twice for each application period. Any alterations to the program and the Request for Application will also be broadcast through these methods. All application documents must be received by 11:59 PM on November 15, 2012. Applicants will be notified of acceptance or denial of the application on or before January 15, following the application deadline. Application Documents Application documents may be obtained online at http://ictr.johnshopkins.edu/ictr/. Click on Connection Request (left side of the page). Scroll down and read about the FCDP. Login with your JHED ID in the yellow box. Under ICTR Services, select the Fisher Center Discovery Program, click Proceed. Applicants are strongly encouraged to review the document Fisher Center Discovery Program Application Guidelines before completing the application. Download the required documents and complete them offline. Complete the FCDP Application Form in its entirety. Identification of research team members will require their JHED ID – please be prepared. Upload all required documents as directed within the application space before the published deadline. NOTE: Once submitted, the application cannot be changed. Non-electronic submissions will not be accepted. Completion of the Fisher Center Discovery Program Application is required for all proposals. Submission of a comprehensive research protocol is required. For studies that involve human participants, use of the Johns Hopkins Medicine Institutional Review Board (JHM IRB) eFormA format is required. The current JHM IRB eFormA-Protocol template may be downloaded from http://www.hopkinsmedicine.org/institutional_review_board/forms/. The submitted protocol must include all sections of the template. If a section is not applicable, leave the heading and insert “NA.” For studies that involve animals, use of the Johns Hopkins University Institutional Animal Care and Use Committee (IACUC) protocol form is required. The current IACUC protocol form template may be downloaded from http://web.jhu.edu/animalcare/forms.html. The submitted protocol must include all sections of the template. Citations which support the research protocol must be uploaded as a separate document. Use the PubMed format. The PubMed Central reference number (PMCID) must be included at the end of citations. Additional information about the PubMed format may be found online at http://www.nlm.nih.gov/bsd/policy/cit_format.html. The current curriculum vitae (Johns Hopkins format) and bibliography for the PI, co-investigators, and fellows, house staff, and students must accompany all applications. The Johns Hopkins CV template may be downloaded from the application space. A letter of support from the Faculty research preceptor (PI) is required for JHU fellows, house staff, medical school students, graduate students, and undergraduate students. Upload as a separate document. All proposals must be accompanied by a budget formatted using the FCDP Budget Template. Upload as a separate document. An explanation of other funding sources that will be used to cover costs not covered by the FCDP is to be included on the FCDP Application, if appropriate. List ICTR services and monetary support that will be requested. Write NA in this section if support from sources other than the FCDP is not anticipated. Justification for exceeding the 50% cap of the monetary award for total salary support must be submitted in the form of a written letter and uploaded within the application space. Budget Instructions The research budget is to be formatted using the FCDP Budget Template. The budget must include personnel costs, consultants, patient care costs, animal care costs, supplies and equipment, and other study related expenses. Do not delete rows. Insert zeros if there are no expenses related to a specific budgetary item. 5 The Sherrilyn and Ken Fisher Center for Environmental Infectious Diseases Discovery Program Johns Hopkins University, School of Medicine, Department of Medicine, Division of Infectious Diseases Additional rows may be added as needed. Please accurately label the rows and place in the correct category. Services requested from the Fisher Center support staff are also included in the budget. Total all project expenses, including Fisher Center Services. Do not exceed $50,000. Enter data in the appropriate area of the budget. The Total Cash Award requested is the total project costs minus the total Fisher Center services cost. Direct budget preparation questions to Yvonne Higgins, 410-614-0440. Application Presentation and Formatting Software Application documents are to be submitted in their original software format (Microsoft Excel for the budget, Microsoft Word for all other documents). Hand written applications will not be accepted Language All applications must be submitted in standard American English If terms are not universally known, spell out the term the first time it is used and note the appropriate abbreviation in parentheses. The abbreviation may be used thereafter. Font Arial or Calibri, 11 points, black type. A symbol font may be used to insert Greek letters or special characters Type density, including characters and spaces, must be no more than 15 characters per inch Type may be no more than six lines per inch Shadings or colors may not be used in text portions of the application Paper Size and Page Layout Use standard size (8.5“ X 11“) sheets of paper Use 0.5 inch margins on all sides (top, bottom, left, and right) for all pages Standard, single-column format for the text Single sided and single spaced Consecutive number pages throughout the application in the footer, centered, on each page. Do not use suffixes (e.g. 1a, 1b) Do not include unnumbered pages Do not include additional blank pages The submission date, principal investigator, and project title should be in the header, in the top right hand corner of each page. Figures, Graphs, Diagrams, Charts, Tables, Figure Legends, and Footnotes A smaller type size is acceptable, but it must be in blank ink, readily legible and follow the font typeface requirement Footnotes are to be consecutively numbered on a separate page Photographs and Images All photographs and other materials must be imbedded directly within the application. Items glued or taped on the application will not be accepted. Up to six black-and-white images may be included if they are critical to the content of the application. The application must contain only material that reproduces well when photocopied in black-and-white Post Submission of Application Materials Application materials will only be accepted after submission of the application if they result from unforeseen administrative issues. Acceptable post-submission materials include: 6 The Sherrilyn and Ken Fisher Center for Environmental Infectious Diseases Discovery Program Johns Hopkins University, School of Medicine, Department of Medicine, Division of Infectious Diseases o o o o o Revised budget due to new funding Letters of support or collaboration resulting from a change in personnel Adjustments resulting from natural disasters News of an article accepted for publication Specific documents requested by the FC Advisory Board Review Process Upon submission, the FCDP will assign an application number. This number will be used on all future FCDP communication with the applicant. The FCDP encourages applicants to communicate with our staff concerning our programs, resources, and granting process. Questions about the application process should be directed to the Fisher Center Senior Research Program Manager, Yvonne Higgins, 410-614-0440, email yhiggins@jhmi.edu. Questions about potential research project topics and selection criteria may be directed to the Fisher Center Director, Dr. Paul Auwaerter, 410-502-6938, email pauwaert@jhmi.edu. Applications will be scored by JHU faculty members with expertise in the field similar to that of the proposed research topic. All applications will be scored on a 1-9 scale in five areas: o Relevance to FCDP goals and environmental infectious diseases o Scientific impact, novelty, and merit in the experimental design o Feasibility of project completion within a twelve month period o Collaboration between investigators and JHU schools o Potential for development of research and/or clinical leadership Only complete applications received by the deadline will be reviewed. The review process is as follows: o FCDP staff will review the application for completeness and compliance with the grant process as outlined above. o Application materials will be distributed to individual Faculty reviewers for preliminary scoring. Reviewers will submit written feedback regarding applications they have scored. o The FC Advisory Board (FCAB) will meet to discuss all applications, assign a final score to applications, and discuss funding awards. o The FCDP Director will finalize the award, including funding. All funding decisions are final. o Applicants will be notified in writing of acceptance or rejection of the application within two months of the submission deadline. o The PI and a representative of the FCDP will sign a written agreement outlining the terms of the award. o The FCDP offers flexible start dates for release of funds, per PI request. The start date window should be no longer than six months after award notification. The start and end date of the twelve month period will be included in the FCDP written agreement. Additional review will not be permitted. Revisions after rejection will not be permitted. 7 The Sherrilyn and Ken Fisher Center for Environmental Infectious Diseases Discovery Program Johns Hopkins University, School of Medicine, Department of Medicine, Division of Infectious Diseases Fisher Center Discovery Program Application and Review Timeline 10/01/12 RFA Publication October 2012 12/31/12 End of Preliminary Review Period November 2012 December 2012 11/15/12 Application Deadline, Reviewers Assigned 01/15/13 Award Notification January 2013 TBD Final Review by FC Advisory Board Award start date: 02/01/13-07/01/13, at investigator discretion Feedback As part of the mentoring objective, feedback to applicants after peer review is very important. All applicants will receive written feedback via the FCAB Review Summary Statement The meaning of numeric designations will be clearly indicated on the FCAB Review Summary Statement. Denied applicants may make an appointment with the FCDP Director to discuss the application review outcome and obtain guidance for future applications. Links to the Fisher Center Discovery Program Documents Library FCDP Request for Application (RFA) FCDP Application FCDP Application Guidelines FCDP Budget Template Johns Hopkins eIRB eFormA template Johns Hopkins University Institutional Animal Care and Use Committee (IACUC) protocol form Johns Hopkins curriculum vitae format 8